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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B

A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults With Chronic Hepatitis B

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. In addition, the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of CRMA-1001 will be evaluated. CRMA-1001 is an epigenetic gene therapy delivered via intravenous (IV) infusion. Up to four dose levels will be tested. Participants will receive a single or multiple doses of CRMA-1001 and will remain on antiviral therapy during the dosing process.

Who May Be Eligible (Plain English)

Who May Qualify: - Male/Female, weight 45-150 kg, age 18-64, inclusive - Diagnosed with Chronic Hepatitis B - On oral antiviral therapy - ALT and AST \<= 1.5 x ULN - Total bilirubin \<= ULN Who Should NOT Join This Trial: - Significant hepatic fibrosis or cirrhosis - Current or prior liver disease other than HBV - Other protocol-defined inclusion/exclusion criteria may apply Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Male/Female, weight 45-150 kg, age 18-64, inclusive * Diagnosed with Chronic Hepatitis B * On oral antiviral therapy * ALT and AST \<= 1.5 x ULN * Total bilirubin \<= ULN Exclusion Criteria: * Significant hepatic fibrosis or cirrhosis * Current or prior liver disease other than HBV * Other protocol-defined inclusion/exclusion criteria may apply

Treatments Being Tested

GENETIC

CRMA-1001

Epigenetic gene silencing therapy delivered by intravenous (IV) infusion

Locations (2)

Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
New Zealand Clinical Research
Auckland, New Zealand